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Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Recalled March 18, 2026 · FDA recall Z-1516-2026 · Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. · FDA Class II
Units
7 units (OUS only)
Sold at
Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
Description
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Manufacturer(s)
Waldemar Link GmbH & Co. KG (Mfg Site)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →